Class II
Drug Recall: Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Indi
Glenmark Pharmaceuticals Inc., USA · March 13, 2025
Reason for Recall
CGMP Deviations
Product Description
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
Distribution
U.S. Nationwide
States Affected
NATIONWIDE
Quantity Affected
N/A
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0332-2025
Status: ongoing
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